Pediatric Subjects The efficacy of the individual components of Triumeq for the treatment of HIV-1 infection was evaluated in pediatric patients enrolled in the impaact P1093 trial (NCT01302847) or the arrow trial (NCT02028676 as summarized below. These events have been included because of their seriousness and/or assessment of potential causal relationship. Treatment with Triumeq should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations. Lamivudine: Based on prospective reports to the APR of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester there was no difference between the overall risk of birth defects for lamivudine compared with the background. Drug-induced liver injury leading to liver transplant has been reported with Triumeq. Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended. The dosing recommendations in this population are based on the safety and efficacy established in a controlled trial conducted using either the combination of epivir and ziagen or epzicom. 2018 ViiV Healthcare group of companies or its licensor. Non-nucleoside reverse transcriptase inhibitor: Etravirinea Dolutegravir Use of Triumeq with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended. Mutagenicity Dolutegravir: Dolutegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay.